Health care compliance professionals who are involved in electronic clinical quality measures (eCQM) submissions should prepare now for their 2017 submissions, according to Catherine Gorman Klug RN, MSN, Director, Quality Service Line, for Nuance Communications. In a Health Care Compliance Association (HCCA) webinar titled, “eCQM Lessons Learned and How to Prepare for 2017 Submissions,” Klug warned attendees about hidden dangers, including the lack of experience for eCQM vendors, inaccurate data submissions, and the challenges posed by multiple types of electronic health record (EHR) data files generated from more than one system. She also gave recommendations for reducing risk and listed sample questions for the information technology (IT) department.

CMS requires hospitals to report eight of 15 eCQMs, with data reported for the entire year. According to Klug, the agency expects “one file, per patient, per quarter,” that includes all episodes for care and measures associated with the patient. Many hospitals use vendors to assist with the eCQM submissions, but Klug noted that vendors must have an adequate amount of time to respond to required changes before submission, and that although many vendors support a broad number of eCQMs, they may lack adequate depth of coverage. Hospitals should choose vendors who are experienced in the eCQMs they are reporting. Further, there is no way to validate the files submitted. Possible consequences include an annual payment update reduction, failure to receive the EHR incentive payment, or poor quality scores on CMS’ Hospital Compare site.

To reduce risks, hospitals should ask the core measures vendor to validate files before submission to CMS. They should also review file error reports from the vendor and make corrections before the data is submitted. Aggregated file error reports should also be reviewed to ensure that formatting or data elements don’t result in an inaccurate submission. Klug said that accurate coding is absolutely essential. Therefore, hospital IT departments should be prepared to explain how files are validated prior to submission to ensure accuracy, and if not, what the remediation strategy is. Further, compliance professionals should request a file error report, and any other reports to help understand the data being submitted.

As health information technology (HIT) evolves and the industry increasingly relies on it, the field represents a niche opportunity for young lawyers. At the American Health Lawyers Association (AHLA) Fundamentals of Health Law conference, presenters Ryann Schneider and Sidney Welch emphasized the necessity of understanding both the technology and regulations as well as maintaining close oversight of vendors. This area presents many pitfalls and compliance is difficult, but essential.

Innovations

At the close of the third quarter of 2016, $6.5 billion in digital health deals were recorded. Clinical operations are finding more uses for technology, as providers use telehealth for specialty consults, chronic care management, monitoring, and diagnosis while patients continue to rely on personal health applications and wearables. These innovations require continued development of oversight strategies.

Statutes and regulations

One challenge for compliance is understanding the changing (and conflicting) rules surrounding telemedicine. CMS has issued and updated telemedicine regulations for Medicare, while Medicaid reimbursement differs between the states. States have also implemented various non-payment laws, such as the definitions of a valid telemedicine encounter and requiring a full license to practice medicine in the state in which the patient is located. There are also intellectual property considerations, as well as dealing with a long list of regulatory agencies from the HHS Office of Inspector General (OIG) and the Department of Justice (DOJ) to the Federal Trade Commission (FTC) and Internal Revenue Service (IRS).

Vendors

When health care entities hire technology vendors, each side has a different level of understanding and priorities. Health care customers are particularly sensitive to safety, outcome commitments, and security than other technology customers, and often overestimate the time and resources required for projects. Vendors are experts on their technology, and have a better idea of the partnership required to successfully implement sophisticated projects.

The speakers noted that counsel does not have to understand the nuts and bolts of the technology, but emphasized the need for a team comprised of both business and tech experts to ensure that all bases are covered. Additionally, if in-house counsel focuses on regulatory understanding, outside technology or intellectual property (IP) counsel can supplement with specialized expertise.